Senior Director, Clinical Operations

This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for a Senior Director, Clinical Operations based in United States.

This executive leadership role offers the opportunity to shape and drive clinical development operations within a dynamic life sciences environment. The position is responsible for translating strategic objectives into operational excellence across clinical, regulatory, quality, and manufacturing functions. You will lead cross-functional teams, manage complex development programs, and ensure successful execution from early research through commercialization. The role requires strong scientific expertise, business acumen, and the ability to build scalable operational frameworks. You will collaborate with senior executives, external partners, and industry stakeholders to accelerate innovative healthcare solutions. This is an impactful opportunity for a seasoned leader who thrives in fast-paced, growth-oriented organizations and wants to influence the future of medicine.

Accountabilities:: The Senior Director, Clinical Operations will provide strategic and operational leadership across the full clinical development lifecycle, ensuring programs are executed efficiently, compliantly, and aligned with organizational goals. This role serves as a key executive partner, driving operational effectiveness, cross-functional collaboration, and the advancement of development initiatives.

Lead clinical operations strategy and execution as a member of the executive leadership team, contributing to corporate planning and strategic decision-making.

Oversee clinical development operations, including trial execution, site activation, enrollment strategies, monitoring activities, data management, safety reporting, and vendor management.

Ensure clinical programs progress according to timelines, budgets, quality standards, and regulatory expectations.

Develop and implement operational plans that support organizational growth, partnerships, financing activities, and long-term objectives.

Identify operational risks, establish mitigation strategies, and promote continuous improvement across development functions.

Provide oversight of nonclinical development activities, including pharmacology, toxicology, bioanalytical programs, and external research partners.

Guide regulatory strategy and execution, ensuring successful interactions with regulatory authorities and alignment with global requirements.

Oversee quality systems and compliance programs, ensuring adherence to GCP, GLP, GMP, ICH guidelines, and applicable regulations.

Lead CMC, manufacturing, supply chain, and external partner activities to ensure clinical supply readiness and manufacturing execution.

Establish integrated development plans, monitor critical milestones, and drive alignment between clinical, regulatory, quality, manufacturing, and program management teams.

Partner with finance leadership on budgeting, forecasting, resource allocation, and operational planning.

Build and maintain strong relationships with CROs, CDMOs, consultants, investigators, strategic partners, investors, and industry stakeholders.

Represent the organization in executive discussions, regulatory interactions, partnership meetings, and business development activities.

Requirements:

The ideal candidate is an experienced biotechnology or pharmaceutical leader with a strong background in clinical operations, organizational scaling, and cross-functional development programs. This professional should combine scientific expertise, operational discipline, and executive communication skills to successfully lead complex initiatives in a rapidly evolving environment.

Advanced scientific degree preferred, including MD, PharmD, PhD, RN, MS, or equivalent relevant experience.

MBA or formal business management training is strongly preferred.

10+ years of progressive leadership experience within biotechnology, pharmaceutical, or life sciences organizations.

Extensive experience overseeing multiple development functions, including clinical operations, regulatory affairs, quality assurance, and manufacturing.

Proven track record managing clinical development programs across multiple phases, from early development through late-stage trials.

Experience supporting IND-enabling activities, regulatory interactions, and global development strategies.

Demonstrated ability to build, scale, and lead high-performing clinical operations organizations.

Strong expertise managing outsourced development models, including CRO and CDMO relationships.

Ability to operate strategically while maintaining strong execution focus in a fast-paced environment.

Excellent leadership, communication, stakeholder management, and decision-making skills.

Strong understanding of regulatory requirements, compliance standards, and operational best practices.

Fluent English communication skills required.

Benefits:

Competitive annual salary range of $175,000 - $195,000 USD , depending on location, experience, qualifications, and role scope.

Flexible remote work environment.

Opportunity to lead high-impact clinical development initiatives within an innovative healthcare-focused organization.

Professional growth opportunities and access to continuous learning and development resources.

Collaboration with a global team of scientists, clinicians, strategists, and industry experts.

Exposure to cutting-edge healthcare, biotechnology, and life sciences projects.

Opportunity to work with international partners and contribute to advancements in patient care.

Comprehensive benefits package and employee support programs.

How Jobgether works: We use an AI-powered matching process to ensure your application is reviewed quickly, objectively, and fairly against the role's core requirements. Our system identifies the top-fitting candidates, and this shortlist is then shared directly with the hiring company. The final decision and next steps (interviews, assessments) are managed by their internal team. We appreciate your interest and wish you the best!  Why Apply Through Jobgether?    Data Privacy Notice: By submitting your application, you acknowledge that Jobgether will process your personal data to evaluate your candidacy and share relevant information with the hiring employer. This processing is based on legitimate interest and pre-contractual measures under applicable data protection laws (including GDPR). You may exercise your rights (access, rectification, erasure, objection) at any time.     #LI-CL1